Ascending Aortic AneurismSTARNCT01787604
Study of Aortic Root Reimplantation Procedure
A study testing Aortic Root Reimplantation Procedure and Aortic Valve Reimplantation Procedure in people with Ascending Aortic Aneurism and Aortic Valve Insufficiency, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascending Aortic Aneurism, Aortic Valve Insufficiency
- What is being tested?
- Aortic Root Reimplantation Procedure and Aortic Valve Reimplantation Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2011to 20 Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aortic insufficiency 2+
- Ascending aorta or aortic root of greater than 4.5 cm (> 4.0 cm in Marfan syndrome)
- Good conditions of aortic cusps
Who cannot join
- Aortic annulus more than 32 mm
- Aortic cusps destruction
- Critical aortic cusps elongation
- Aortic root dissection
Trial locations and contacts
1 site in 1 country.
Russia1 site
Meshalkin State Research Institute of Circulation Pathology
Novosibirsk, 630055
About this study
Official title: Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure
Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.
Read the detailed description
A single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of aortic valve replacement between the standard aortic valve reimplantation procedure and aortic root reimplantation procedure more than 21.1%. If there is truly difference between groups (Aortic Root Reimplantation Procedure and Aortic Valve Reimplantation Procedure), then total 64 patients for both groups are required to be 80% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the Aortic Root Reimplantation Procedure of 21.1%. The blinding process is applied to a patient, who is informed about received valve-sparing operation, but don't know the type of the last. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: Aortic Root Reimplantation Procedure group includes 32 patients and Aortic Valve Reimplantation Procedure group consists of 32 patients. Randomization is conducted intraoperatively by using accidental sampling after examining the aortic valve and making a decision on the possibility of a valve-sparing operation.
- Being tested
- Aortic Root Reimplantation Procedure, Aortic Valve Reimplantation Procedure
- Keywords
- Valve-sparing, Valve repair
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic Root Reimplantation ProcedureProcedure or surgery
Also called Modified Florida Sleeve.
Modified Florida Sleeve.
Aortic Valve Reimplantation ProcedureProcedure or surgery
Also called David I
David I
| Study group | Role | What they receive |
|---|---|---|
| Aortic Root Reimplantation Procedure | Active comparator | Aortic Root Reimplantation Procedure Receives: Procedure: Aortic Root Reimplantation Procedure |
| Aortic Valve Reimplantation Procedure | Active comparator | Aortic Valve Reimplantation Procedure Receives: Procedure: Aortic Valve Reimplantation Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)
Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment..
Measured: up to 4 yeras
Secondary outcomes (1)
Survival (Percentage, Kaplan-Meier)
Estimated percentage of alive participants for 4 years after treatment.
Measured: up to 4 yeras
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJan 2011
- Primary completion20 Nov 2015
- Study completion20 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ascending Aortic AneurismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Dmitry Khvan, Meshalkin Research Institute of Pathology of Circulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787604
- Sponsor's protocol ID
- STAR
- Acronym
- STAR
- Status last verified
- Mar 2019
- First submitted
- 30 Jan 2013
- Last updated
- 10 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Alexander Chernyavskiy, Sergey Alsov, Dmitry Khvan, Dmitry Sirota. Extravalvular exoprosthetic repair of aortic root: first experience. Kardiochirurgia i Torakochirurgia Polska 2012; 9 (4): 409-414 DOI: 10.5114/kitp.2012.32675
Чернявский А. М., Хван Д. С., Альсов С. А., Сирота Д. А., Ляшенко М. М. Результаты реимплантации корня аорты в протез у пациентов с аневризмой восходящего отдела аорты и недостаточностью аортального клапана. Патология кровообращения и кардиохирургия. 2015;19(4):38-47. http://dx.doi.org/10.21688/1681-3472-2015-4-38-47
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure
- ClinicalTrials.gov ID
- NCT01787604
- Acronym / sponsor ID
- STAR / STAR
- Keywords
- Valve-sparing, Valve repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jan 2011 (actual)
- Primary completion
- 20 Nov 2015 (actual)
- Study completion
- 20 Nov 2015 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Posted 10 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.
Detailed description
A single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of aortic valve replacement between the standard aortic valve reimplantation procedure and aortic root reimplantation procedure more than 21.1%. If there is truly difference between groups (Aortic Root Reimplantation Procedure and Aortic Valve Reimplantation Procedure), then total 64 patients for both groups are required to be 80% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the Aortic Root Reimplantation Procedure of 21.1%. The blinding process is applied to a patient, who is informed about received valve-sparing operation, but don't know the type of the last. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: Aortic Root Reimplantation Procedure group includes 32 patients and Aortic Valve Reimplantation Procedure group consists of 32 patients. Randomization is conducted intraoperatively by using accidental sampling after examining the aortic valve and making a decision on the possibility of a valve-sparing operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aortic Root Reimplantation Procedure | Active comparator | Procedure: Aortic Root Reimplantation ProcedureAortic Root Reimplantation Procedure |
| Aortic Valve Reimplantation Procedure | Active comparator | Procedure: Aortic Valve Reimplantation ProcedureAortic Valve Reimplantation Procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aortic insufficiency 2+
- Ascending aorta or aortic root of greater than 4.5 cm (> 4.0 cm in Marfan syndrome)
- Good conditions of aortic cusps
Key exclusion criteria (4 listed)
- Aortic annulus more than 32 mm
- Aortic cusps destruction
- Critical aortic cusps elongation
- Aortic root dissection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aortic Root Reimplantation ProcedureAlso: Modified Florida Sleeve.Modified Florida Sleeve. | Procedure or surgery | Aortic Root Reimplantation Procedure |
| Aortic Valve Reimplantation ProcedureAlso: David IDavid I | Procedure or surgery | Aortic Valve Reimplantation Procedure |
Primary outcome
Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)
Time frame: up to 4 yeras
Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment..
1 secondary outcome
Survival (Percentage, Kaplan-Meier)
Time frame: up to 4 yeras
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationAlexander Chernyavskiy, Sergey Alsov, Dmitry Khvan, Dmitry Sirota. Extravalvular exoprosthetic repair of aortic root: first experience. Kardiochirurgia i Torakochirurgia Polska 2012; 9 (4): 409-414 DOI: 10.5114/kitp.2012.32675
- Results publicationЧернявский А. М., Хван Д. С., Альсов С. А., Сирота Д. А., Ляшенко М. М. Результаты реимплантации корня аорты в протез у пациентов с аневризмой восходящего отдела аорты и недостаточностью аортального клапана. Патология кровообращения и кардиохирургия. 2015;19(4):38-47. http://dx.doi.org/10.21688/1681-3472-2015-4-38-47
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aortic Root Reimplantation Procedure and Aortic Valve Reimplantation Procedure in people with Ascending Aortic Aneurism and Aortic Valve Insufficiency, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) (time frame: up to 4 yeras). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01787604, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.